10 mg film-coated tablet
montelukast
What Montelukast Mylan is and what it is used for
Montelukast Mylan contains montelukast, a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause contraction and swelling of the airways in the lungs and also cause allergic symptoms. By blocking the leukotrienes, Montelukast Mylan improves the symptoms of asthma, helps control asthma, and improves the symptoms of seasonal allergies (so-called hay fever or seasonal allergic rhinitis ).
Your doctor has prescribed Montelukast Mylan to treat your asthma and thus prevent asthma symptoms during the day and night.
- Montelukast Mylan is used for the treatment of adults and adolescents, 15 years and older who have not received adequate control of previous asthma medication and therefore need additional treatment.
- Montelukast Mylan also prevents the contraction of the airways in connection with physical exertion.
- Montelukast Mylan can also be used for seasonal allergic rhinitis in patients where Montelukast Mylan is used to treat asthma
Depending on your symptoms and the severity of your asthma, your doctor will decide how to use Montelukast Mylan.
Montelukast Mylan 10 mg tablet is only for adults and adolescents from 15 years of age.
Montelukast contained in Montelukast Mylan may also be authorized for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What is asthma?
Asthma is a chronic disease.
Asthma includes:
- Breathing difficulties due to airway constriction. This contraction of the airways is made more difficult and improved due to different conditions.
- Sensitive airways that react to various stimuli, e.g. tobacco smoke, pollen, cold air or physical exertion.
- Swelling ( inflammation ) of the mucous membranes of the airways.
Symptoms of asthma include cough, wheezing, and tightness in the chest.
What is a seasonal allergy?
Seasonal allergy (also called hay fever or seasonal allergic rhinitis) is an allergic reaction that is often caused by airborne pollen from trees, grass, or weeds. The symptoms of seasonal allergy are characterized by: stuffy, runny, and itchy nose; sneezing; watery, swollen, red, and itchy eyes.
What you need to know before taking Montelukast Mylan
Tell your doctor about any medical or allergic problems you may have or have had.
Do not take Montelukast Mylan
- if you are allergic to montelukast or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor or pharmacist before taking Montelukast Mylan.
- If your asthma or breathing worsens, contact your doctor immediately.
- Montelukast Mylan is not indicated for the treatment of acute asthma attacks. If an attack occurs, follow the instructions given by your doctor for this situation. Always carry your inhaled bronchodilator asthma medication with you for acute asthma attacks. Talk to your doctor if you feel you need to take a higher dose than you usually take for acute asthma attacks.
- It is important that you take all asthma medications prescribed by your doctor. Montelukast Mylan is not intended to replace other asthma medicines prescribed by your doctor.
- All patients treated with asthma medication should be aware that if he / she develops a combination of different symptoms, such as flu-like symptoms , tingling or numbness in the arms or legs, worsening respiratory symptoms and / or skin rash, a doctor should be contacted.
- If you know that asthma is aggravated by acetylsalicylic acid or other anti- inflammatory drugs ( NSAIDs ), then do not use these drugs.
- Patients should be aware that various neuropsychiatric events (such as behavioral and mood-related changes) have been reported in adults, adolescents and children with Montelukast Mylan (see section 4). If you or your child develop such symptoms while using Montelukast Mylan, you should contact your doctor.
Children and young people
Do not give this medicine to children under 15 years of age.
There are other dosage forms of this drug available for children and adolescents under 18 years of age based on age group.
Other medicines and Montelukast Mylan
Some medicines may affect the way Montelukast Mylan works and Montelukast Mylan may affect the way other medicines work.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Tell your doctor or pharmacist if you are taking the following medicines before starting treatment with Montelukast Mylan:
- phenobarbital (antiepileptic drugs )
- phenytoin (antiepileptic drugs )
- rifampicin (remedy for tuberculosis and certain other infections )
- gemfibrozil (antihypertensive agent)
Pregnancy, breastfeeding and fertility
Pregnancy
If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will decide if you can take Montelukast Mylan during this time.
Breast-feeding
It is unknown whether Montelukast Mylan passes into breast milk. Therefore, talk to your doctor before using Montelukast Mylan if you are breastfeeding or planning to breastfeed.
Driving and using machines
Montelukast Mylan is not expected to affect your ability to drive or use machines. However, individual reactions to the drug have occurred. Some side effects reported with montelukast (such as dizziness and drowsiness) may affect some patients’ ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Montelukast Mylan contains para-orange and sodium
Para-orange (E110) may cause allergic reactions. This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’.
How to take Montelukast Mylan
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
- Take only one tablet of Montelukast Mylan a day as prescribed by your doctor .
- It is important that you continue to take Montelukast Mylan daily both during asymptomatic periods or if you have an acute asthma attack.
Adults (including the elderly) and adolescents 15 years and older:
The recommended dose is:
- One 10 mg tablet taken once daily in the evening.
Children and young people
Montelukast Mylan is not suitable for children or adolescents under 15 years.
If you are taking Montelukast Mylan, make sure that you do not take any other medicine that contains the same active substance, montelukast.
This medicine should be taken by mouth.
Montelukast Mylan can be taken with or without food.
If you take more Montelukast Mylan than you should
In the majority of reports of overdose, no side effects have been reported. The most common symptoms reported with overdose included stomach pain, drowsiness, thirst, headache, vomiting, and overactivity.
If you forget to take Montelukast Mylan
Try to take Montelukast Mylan as prescribed. If you have missed a dose, return to the usual schedule with one tablet a day.
Do not take a double dose to make up for a forgotten dose.
If you stop taking Montelukast Mylan
Montelukast Mylan can only treat your asthma if you continue to take it.
You must continue to take Montelukast Mylan for as long as your doctor prescribes it. It helps control your asthma.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
In clinical trials with montelukast 10 mg film-coated tablets, the most commonly reported adverse reactions (occurring in up to 1 patient in 10) were likely to occur:
• magnet
• headache
These were usually mild and were more common in patients treated with montelukast than placebo (a pill that does not contain any medicine).
Serious side effects are
Talk to your doctor immediately if you notice any of the following side effects that may be serious and where you may need urgent medical attention.
Uncommon: may affect up to 1 in 100 people
- allergic reactions including swelling of the face, lips, tongue and / or throat, which may cause breathing or swallowing difficulties
- behavioral and mood changes: anxiety / upset including aggressive behavior or hostility, depression
- seizures
Rare: may affect up to 1 in 1,000 people
- increased tendency to bleed
- tremors
- palpitation
Very rare: may affect up to 1 in 10,000 people
- combination of symptoms, such as flu-like symptoms , tingling or numbness in the arms and legs, aggravated respiratory symptoms and / or rash (Churg ‑ Strauss syndrome) (see section 2)
- decreased platelet count
- behavioral and mood changes: hallucinations, disorientation, suicidal thoughts and acts
- swelling ( inflammation ) of the lungs
- severe skin reactions (erythema multiforme) that may occur without warning
- hepatitis _ _
Other side effects have been reported during the time the drug has been on the market
Very common: may affect more than 1 user in 10
- upper respiratory tract infection
Common: may affect up to 1 in 10 users
- diarrhea, nausea, vomiting
- rash
- fever
- elevated liver enzymes
Uncommon: may affect up to 1 in 100 people
- Behavioral and Mood Changes: Changed Dream Patterns Including Nightmares, Insomnia, Sleepwalking, Irritability, Anxiety, Restlessness
- dizziness, drowsiness, numbness and tingling
- nosebleeds
- dry mouth , indigestion
- bruising, itching , hives
- joint or muscle aches, muscle cramps
- bedwetting in children
- weakness / fatigue, general malaise, swelling
Rare: may affect up to 1 in 1,000 people
- Behavioral and Mood Changes: Attention Deficit Hyperactivity Disorder, Involuntary Muscle Movement
Very rare: may affect up to 1 in 10,000 people
- sore red bumps under the skin, preferably on the shins (erythema nodosum)
- behavioral and mood changes: obsessive-compulsive disorder, stuttering
How to store Montelukast Mylan
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label, carton, and blister after EXP. The expiration date is the last day of the specified month.
No special storage instructions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is montelukast
- Each tablet contains 10 mg of montelukast as montelukast sodium
- Other ingredients are:Tablet core : microcrystalline cellulose, mannitol, croscarmellose sodium, magnesium stearate, sodium lauryl sulphate, colloidal anhydrous silicaTablet coating : polydextrose, titanium dioxide (E171), hypromellose, triacetin, macrogol, indigo carmine-aluminum lacquer (E132), para-orange-aluminum lacquer (E110) (see section 2 “Montelukast Mylan contains para-orange”)
What the medicine looks like and contents of the pack
Blue, round, biconvex film-coated tablets with a beveled edge marked “MO” over “10” on one side and “M” on the other side.
Montelukast Mylan 10 mg tablet is available in blisters containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90 and 100 tablets or in perforated unit dose blisters containing 28×1 tablets or in cans of desiccant gel containing silica gel 28, 30, 56, 60, 84, 90, 100, 112, 120, 180 and 500 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
McDermott Laboratories Ltd, t / a Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., H-2900 Komárom, Mylan utca.1, Hungary
Mylan BV Krijgsman 20, Amstelveen, 1186DM, The Netherlands.
Logiters, Logística Portugal, SA Estrada dos Arneiros, 4, Azambuja, 2050-544, Portugal